Nasdaq3d
Alvotech: FDA To Review BLA For AVT05 - Quick Facts
The FDA review process is anticipated to be completed ... and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New ...
Nasdaq3d
Invivyd Submits Updated Immunobridging Data To FDA For PEMGARDA EUA Amendment
Invivyd has continued to provide timely updates to the FDA since its initial submission ... author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew ...
Nasdaq2d
FDA Expands Label of AZN's Enhertu for New Breast Cancer Indication
AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu (trastuzumab ...
Nasdaq1d
FDA Clears Allogene's IND for CAR T Therapy in Autoimmune Diseases
Allogene Therapeutics, Inc. ALLO announced that the FDA has cleared its investigational new drug (IND) application to begin clinical studies on its investigational CRISPR-based allogenic CAR-T ...
Nasdaq3d
Cartesian Therapeutics Secures FDA SPA Agreement For Phase 3 AURORA Trial
Descartes-08 has received Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation from the FDA for MG and other ... reflect those of Nasdaq, Inc. Founded in the late 1990s ...
Nasdaq3d
Cartesian Therapeutics Announces FDA Special Protocol Assessment Agreement for Phase 3 AURORA Trial of Descartes-08 in Myasthenia Gravis
The SPA agreement indicates that the FDA has determined that the proposed ... of the author and do not necessarily reflect those of Nasdaq, Inc. Sign up for our newsletter to get the latest ...
Nasdaq10d
AstraZeneca Secures FDA Nod for New ADC Drug Datroway in Breast Cancer
AstraZeneca AZN announced that the FDA has approved its antibody-drug conjugate (ADC), datopotamab deruxtecan (or Dato-DXd), in patients with a certain type of breast cancer. The drug ...
Nasdaq7d
Biogen Says FDA And EMA Accept Applications For Higher Dose Regimen Of Nusinersen In SMA
(RTTNews) - Biogen Inc. (BIIB) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted the ... do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s ...
AFP1h
Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has ...
Nasdaq8d
Elicio Therapeutics Receives Supportive FDA Feedback for ELI-002 Phase 3 Study Design, Gains Momentum for Cancer Immunotherapy Development
Received supportive FDA feedback on key elements of the potential ... Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics” or “Elicio”), a clinical-stage biotechnology company ...
Nasdaq13d
FDA Okays AstraZeneca And Daiichi's Datroway For Metastatic HR-Positive, HER2-Negative Breast Cancer
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...
Nasdaq9d
JNJ's SNDA For Spravato Monotherapy Gets FDA Approval For Treatment-Resistant Depression
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...